Objective With a vaccine effectiveness of 95% for preventing coronavirus disease 2019 (COVID‐19), Pfizer‐BioNTech BNT162b2 (BNT162b2) was the first vaccine against severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) to be approved. However, immunosuppressive therapy was an exclusion criterion in the phase 3 trial that led to approval. Thus, extrapolation of the trial results to patients with rheumatic diseases treated with immunosuppressive drugs warrants caution. Methods Patients with systemic lupus erythematosus (SLE; n = 61) and rheumatoid arthritis (RA; n = 73) were included from the COPANARD (Corona Pandemic Autoimmune Rheumatic Disease) cohort, followed since the beginning of the COVID‐19 pandemic. Patients received the BNT162b2 vaccine between December 2020 and April 2021. All patients had total antibodies against SARS‐CoV‐2 measured before vaccination and 1 week after the second vaccination (VITROS Immunodiagnostic Products). Results Of 134 patients (median age, 70 years), 77% were able to mount a detectable serological response to the vaccine. Among patients treated with rituximab, only 24% had detectable anti–SARS‐CoV‐2 antibodies in their serum after vaccination. The time since the last rituximab treatment did not seem to influence the vaccine response. No significant difference was observed between patients with RA or SLE when adjusting for treatment, and no correlation between antibody levels and age was detected ( r = −0.12; P = 0.18). Conclusion Antibody measurements against SARS‐CoV‐2 in patients with RA and SLE after two doses of the BNT162b2 vaccine demonstrated that 23% of patients could not mount a detectable serological response to the vaccine. B cell–depleting therapy (BCDT) is of specific concern, and our findings call for particular attention to the patients receiving BCDT.

Vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) were launched in December 2020. Vaccination of patients with rheumatic diseases is recommended, as they are considered at higher risk of severe COVID-19 than the general population. Patients with rheumatic disease have largely been excluded from vaccine phase 3 trials. This study explores the safety and reactogenicity of BNT162b2 among patients with rheumatic diseases. Patients with systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA), median age 58.8 years, 285 subjects in total, were vaccinated twice with the BNT162b2 (Pfizer/BioNTech). Questionnaires on reactogenicity matching the original phase 3 study were answered seven days after completed vaccination. The majority of SLE and RA patients experienced either local (78.0%) or systemic reactions (80.1%). Only 1.8% experienced a grade-4 reaction. Compared to the original study, we found more frequent fatigue [Odds ratio (OR) 2.2 (1.7-2.8)], headache 2)], muscle pain 3)], and joint pain ] in patients. In contrast, the use of antipyretics was less frequent [OR 0.5 (0.3-0.6)]. Patients with SLE and RA experience reactogenicity to the Pfizer-BioNTech BNT162b2 COVID-19 vaccine. Reactogenicity was more frequent in patients, however, not more severe compared with healthy controls.

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Objective We aimed to investigate if patients with rheumatic diseases treated with rituximab raise a serological response towards the COVID-19 mRNA vaccines and to elucidate the influence of time since the last dose RTX before vaccination on this response. Methods We identified and included 201 patients with rheumatic diseases followed at the out-patient clinic at the Department of Rheumatology, Aarhus University Hospital, who had been treated with RTX in the period 2017-2021 and who had finished their two-dose vaccination with a COVID-19 mRNA vaccine. Total antibodies against SARS-CoV2 spike protein were measured on all patients and 44 blood donors as a reference. Results We observed a time-dependent increase in antibody response as the interval from the last RTX treatment to vaccination increased. Only 17.3% of patients developed a detectable antibody response after receiving their vaccination 6 months or less after their previous RTX treatment. Positive antibody response increased to 66.7% in patients who had RTX 9-12 months before vaccination. All blood donors (100%) had detectable antibodies after vaccination. Conclusion Patients with rheumatic diseases treated with rituximab have a severely impaired serological response towards the COVID-19 mRNA vaccine. Our data suggest that the current recommendations of a 6 months interval between rituximab treatment and vaccination should be revised.

Twenty-one ankle joints with recurrent lateral instability, treated with surgical repair by the Watson-Jones method, were included in a follow-up study 1--5 years after operation. Good results were achieved in 80 per cent. However, the results were not better than those after free dissection and direct suture of the ligamentous ruptures. It is therefore recommended that the more extensive Watson-Jones procedure be reserved for selected cases.